Abstract
PurposeTicagrelor is an orally administered, reversibly binding, direct-acting P2Y12 receptor antagonist previously evaluated in several phase III trials. This phase IV, multicenter, single-arm trial assessed the safety and incidence of cardiovascular (CV) events with ticagrelor in Chinese patients experiencing an acute coronary syndrome (ACS).MethodsPatients hospitalized with an ACS received ticagrelor (180 mg loading dose, 90 mg twice daily thereafter) plus low-dose aspirin (75–100 mg/day) for up to 12 months. Safety was evaluated via PLATO-defined bleeding events, adverse events (AEs), serious AEs, and laboratory measurements. The incidence of major CV events was also evaluated.ResultsThe safety population included 2001 patients. During ticagrelor treatment, 426 (21.3%) patients had at least one PLATO-defined bleeding AE, mainly minimal bleedings (n = 333). Major bleeding events occurred in 27 (1.3%) patients, including fatal/life-threatening bleeding in 17 (0.8%) patients and other major bleeding in 11 (0.5%) patients, with a Kaplan-Meier estimate of patients with the event (95% CI) of 1.6% (1.1–2.3%). In total, 784 (39.2%) patients had at least one non-bleeding AE, the majority of which were mild in severity. The composite endpoint of CV death, myocardial infarction, and stroke occurred in 83 (4.1%) patients.ConclusionsTicagrelor plus low-dose aspirin for up to 1 year was associated with a low rate of major bleeding events and a low incidence of major CV events (CV death, myocardial infarction, stroke) in Chinese patients with ACS. The overall safety profile of ticagrelor in this population was in line with current prescribing information.
Highlights
~ 230 million individuals have cardiovascular disease (CVD) in China [1]
The DAYU study described the safety and rate of CV events during ticagrelor treatment in a large cohort of Chinese acute coronary syndrome (ACS) patients, a population with limited data when ticagrelor was approved in China in 2012
The DAYU study demonstrated that ticagrelor 90 mg twice daily with low-dose aspirin for up to 1 year is associated with a low incidence of major bleeding events and serious adverse event (SAE), and a low incidence of major CV events in Chinese patients with ACS
Summary
~ 230 million individuals have cardiovascular disease (CVD) in China [1]. Chinese patients experiencing an acute coronary syndrome (ACS)—encompassing unstable angina, non-ST elevation myocardial infarction (NSTEMI), and ST elevation myocardial infarction (STEMI)—have a high mortality rate [2, 3]. Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor (ticagrelor, clopidogrel or prasugrel for ≥ 12 months) represents the cornerstone of ACS management [5,6,7,8,9]. Ticagrelor with low-dose aspirin is approved in more than 100 countries (including China) to reduce the rate of CV death, myocardial infarction (MI), and stroke in ACS patients (180 mg loading dose 90 mg twice daily [b.i.d] for the first year post-ACS event) [13]. In some countries and regions (e.g., USA, Japan, Hong Kong, and EU countries), ticagrelor is approved to reduce the rate of CV death, MI, and stroke in patients with a history of MI (60 mg b.i.d from 1 year post-MI)
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
